Whey Protein Pre-load and Postprandial Glycemia in Pregnancy (ProGs)

Effect of Whey Protein on Postprandial Glucose Excursions in Pregnant Women

This pilot study aims to investigate the intake of whey protein prior to carbohydrate intake as an approach to modulate postprandial glucose excursions during pregnancy.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Postprandial Glycemia
• Intervention / Treatment: Dietary supplement: Whey protein-preload OGTT

Detailed Description

Gestational diabetes (GDM) has transgenerational health consequences and increases the risk of type 2 diabetes mellitus in both mother and child. However, there is a lack of practical nutritional concepts for the prevention and treatment of GDM. This randomized controlled pilot study investigates whether the intake of a protein drink before carbohydrate intake lowers postprandial blood glucose levels of pregnant women. Therefore, two 75g oral glucose tolerance tests are performed in 20 pregnant women in a cross-over design, whereby a whey protein solution is drunk 30 minutes before one of the oral glucose tolerance tests (OGTT). If a clinically relevant effect on blood glucose levels is identified, this project can clarify whether the reduction in postprandial glycemia was caused by changes in the secretion of insulin and incretins.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ulm, Germany, 89081
    • Universityhospital Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pregnant women between 24+0 and 27+6 (+/- 7 days) weeks of pregnancy after menstruation
• BMI before pregnancy: 18 - 29.9 kg/m2
• No known underlying diseases
• Understanding and voluntary signing of a consent form before study-related examinations

Exclusion Criteria:

• Age < 18 years
• Diabetes mellitus type 1 or type 2
• Drug therapy that raises or lowers blood sugar, e.g. steroids, antidiabetics, insulin.
• Endocrine disorders (e.g. hyperthyroidism, polycystic ovary syndrome (PCOS), ...)
• Current depression or other mental illnesses
• Eating disorder
• Regular intake of medication other than vitamins/trace elements during pregnancy
• Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m²
• C-reactive protein > 10 mg/l
• Transaminase elevation of 2 times the upper norm
• Pre-existing cardiac diseases
• Drug and/or alcohol abuse
• Hb < 12 g/dl
• No consent to be informed about incidentally discovered pathological findings
• Any other (clinical) condition that would endanger participants safety or question scientific success according to the physicians opinion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral glucose tolerance test with whey protein pre-load; 30 minutes prior to the 75 g OGTT, a whey protein solution is given.	Dietary supplement: Whey protein-preload OGTT; Intake of 25 g whey protein diluted in water 30 minutes prior to the start of a regular 75 g oral glucose tolerance test
No Intervention: Control oral glucose tolerance; 75 g OGTT without whey protein pre-load.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose course	Course of plasma glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Postprandial glucose excursion	Area under the glucose curve (AUC 0-30 Min. and AUC 0-120 Min.) and peak glucose assessed during a 75 g oral glucose tolerance test with vs without whey protein pre-load in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin course	Course of insulin assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
C-peptide course	Course C-peptide assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Insulin secretion	Insulin secretion assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Insulin sensitivity	Insulin sensitivity assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Glucagon course	Course of glucagon and area under the glucagon curve assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
GLP-1 course	Course of glucagon-like peptide 1 (GLP-1) and area under the GLP-1 curve assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
GIP course	Course of glucose-dependent insulinotropic polypeptide (GIP) and area under the GIP curve assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.
Glicentin course	Course of glicentin and area under the glicentin curve assessed during the 75 g oral glucose tolerance test in pregnant women.	Timepoint 0-120 minutes during the oral glucose tolerance test.

Collaborators and Investigators

• Sponsor: University of Ulm
• Investigators: Principal Investigator: Martin martin.heni@uniklinik-ulm.de, Prof., University Hospital Ulm

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): April 17, 2025
• Study Completion (Actual): October 22, 2025

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: pregnancy; incretins; insulin secretion; whey protein; gestational diabetes mellitus; glycemia; postprandial glucose excursions; protein pre-load
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational
• Other Study ID Numbers: 78/23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No